Updated NCCN® Guidelines Recognize MammaPrint® UltraLow Risk Result, Highlighting its Clinical Utility for Women with Early-Stage Breast Cancer Who Can Safely Forgo Toxic Treatments with Excellent Survival Rates

• Includes level one evidence that MammaPrint can help prevent unnecessary chemotherapy¹ and endocrine therapy²
• Confirms Agendia’s unique ability to identify tumors that have a very low risk of distant metastasis which can have implications for reducing the overtreatment of many women without impacting outcomes

Agendia, Inc., a leader in breast cancer gene expression profiling, today announced the updated National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines in Oncology – Breast Cancer Version 1.2023, recognize Agendia’s MammaPrint UltraLow Risk result and its proven impact on patient care. This inclusion is particularly critical for women with early-stage breast cancer who receive an UltraLow Risk test result and can safely forgo toxic treatments yet maintain excellent chance of survival. The NCCN’s recognition of this risk category will enable clinicians to confidently identify which tumors have an exceedingly low risk of distant metastasis, ultimately empowering them and their patients to determine the best possible path towards a cure while minimizing unnecessary treatment.

Breast cancer is extremely complex, with each tumor having its own biology, clinical behavior, and therapy. Providers need more than what pathology alone can offer to navigate this complexity, yet many conventional tests use broad stroke risk assessments with inherent blind spots. MammaPrint is the only FDA-cleared test that can identify very low risk (UltraLow Risk) tumors, which are proven to have excellent outcomes with de-escalated treatment plans. With the NCCN Guidelines recognizing the value of the MammaPrint UltraLow Risk data, clinicians can further personalize care for these women and avoid over treatment. The updated Guidelines showcase strong evidence that supports the clinical utility of a MammaPrint UltraLow Risk result, including:

• Identifying women with early-stage breast cancer who can safely forgo chemotherapy. NCCN highlights a peer-reviewed publication in The Journal of Clinical Oncology, which stems from Agendia’s randomized control trial, MINDACT, where women with an UltraLow Risk result showed an 8-year breast cancer specific survival (BCSS) above 99%.¹ Furthermore, the supplement to the publication included data by age³ and found the majority of the premenopausal women with a MammaPrint UltraLow Risk result and did not undergo chemotherapy had an excellent distant metastasis free interval (DMFI) at 5 years of 97.1%.² This means it is possible for these women to be spared the serious and often life-threatening long-term effects of chemotherapy, including the potential loss of fertility.
• Identifying postmenopausal women with early-stage breast cancer who can safely discontinue endocrine therapy after 2-5 years.* NCCN also now cites a study in JAMA Oncology that found 20 years after their diagnosis, postmenopausal women with early-stage breast cancer had a 97% BCSS rate with 2-5 years of tamoxifen.² This allows clinicians to identify those who can safely discontinue endocrine therapy early and avoid unnecessary toxicity.*

“Whether it’s chemotherapy or endocrine therapy, no woman should unnecessarily endure treatment and its potential long-term impacts unnecessarily. However, relying on pathologic insights alone can lead to overtreatment. This recognition from the prestigious NCCN acknowledges the robust evidence of MammaPrint’s UltraLow Risk assessment, enabling providers to deliver more personalized care, and allowing women to feel confident they can safely avoid certain treatments and the consequential toxicity,” said Suzanne A Hoekstra, MD, FACS, at Northern Light Mercy Breast Care.

“The MammaPrint UltraLow Risk data are now recognized by NCCN Guidelines, supporting the value of MammaPrint testing to identify these women with an UltraLow Risk of distant metastasis,” said William Audeh, MD, Chief Medical Officer of Agendia. “The clinical implications of an UltraLow Risk result are significant, allowing women and their clinicians to consider reducing endocrine therapy in the face of toxicity, for postmenopausal women, as well as avoiding unnecessary chemotherapy, for premenopausal women, while still experiencing excellent outcomes, free of breast cancer.”

In addition to Agendia’s UltraLow gene expression profile, the MammaPrint test also stratifies breast cancer tumors into additional risk categories. Each of these proprietary signatures was developed through a robust analysis of the RNA signal from 70 different genes in the tumor, each of which helps guide personalized treatment plans for that individual tumor, rather than being based on the cancer type of the average woman. When MammaPrint is combined with Agendia’s BluePrint® test, clinicians also get an assessment of the dominant pathway driving the tumor’s growth. With biology-based insights provided by Agendia’s tests, clinicians can uncover the underlying diversity of every tumor, and in turn, make precise decisions with their patients, that both can rely on.

About Agendia

Agendia is a mission-driven, commercial stage company focused on enabling optimized decision-making by providing physicians with next-generation diagnostic and information solutions that can be used to help improve outcomes for breast cancer patients worldwide. The company currently offers two commercially-available genomic profiling tests that help surgeons, oncologists and pathologists to personalize treatment for women at critical intervention points throughout their patient journey.

MammaPrint^® is a 70-gene prognostic test that, along with other clinicopathologic factors, determines a specific patient’s breast cancer recurrence risk. BluePrint^® is an 80-gene molecular subtyping test that identifies the underlying biology of an individual breast cancer to provide information about its behavior, long-term prognosis and potential response to systemic therapy. Together, MammaPrint^® and BluePrint^® provide a holistic view of the biology underlying an individual patient’s breast cancer, enabling physicians to objectively select the best treatment plan.

For more information on Agendia’s assays and ongoing trials, please visit www.agendia.com.

References

*In lymph node-negative patient type.

¹Lopes Cardozo J, et al. Outcomes of patients with an ultralow-risk 70-gene signature in the MINDACT trial. Journal of Clinical Oncology. 2022; 40(12): 1335-1345.

²Esserman, L, et al. Postmenopausal patients with UltraLow risk in the Stockholm Tamoxifen trial had a 20-year breast cancer specific survival of 97% with 2-5 years of Tamoxifen. JAMA Oncology. 2017; 13(11): 1503-1510.

³Lopes Cardozo J, et al. Outcomes of patients with an ultralow-risk 70-gene signature in the MINDACT trial. Journal of Clinical Oncology. 2022; Supplement.

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